The Effects of Esmolol on the Hemodynamic Response to Orotracheal Extubation

NCT04264286 | Unknown Phase 4

• 1 other identifier: Esmolol and extubation
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Beta-blockers are useful tools for the prevention of hemodynamic instability in the manipulation of airways. The main objective of the present study is to evaluate the effectiveness of using esmolol in attenuating hemodynamic responses at the time of tracheal extubation, by assessing the incidence of tachycardia in relation to placebo.

Conditions

Beta Blocker; Hemodynamic Instability

Keywords

Esmolol; Extubation; Hemodynamic instability

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events as tachycardia

  Intraoperative hemodynamic stability analysis through the incidence tachycardia

  Through study completion, an average of 15 minutes (during awakening from anesthesia)

Study Arms (2)

Esmolol group

ACTIVE COMPARATOR

Patients will receive intravenous esmolol after the end of the surgical procedure.

Drug: Prophylactic esmolol

Placebo group

PLACEBO COMPARATOR

Patients will receive intravenous saline after the end of the surgical procedure.

Drug: Placebo

Interventions

Prophylactic esmolol DRUG

Patients will receive prophylactic esmolol after the end of the surgery

Esmolol group

Placebo DRUG

Patients will prophylactic placebo after the end of the surgery

Placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged between 18 and 60 years, electively scaled for surgery requiring general anesthesia.
• Physical State 1, 2 or 3 of the American Society of Anesthesiology (ASA)

You may not qualify if:

• Patients with cardiac disease
• Patients with renal disease
• Patients with liver disease
• Patient with lung disease
• Patients using beta blockers or calcium channel blockers
• Patients who refuse to participate in the study after presenting the informed consent form

Sponsors & Collaborators

• Hospital de Base: lead

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Federal District, 70335900, Brazil

RECRUITING

Study Officials

• Fabricio T Mendonça, MD, MSc

  Hospital de Base do Distrito Federal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabricio T Mendonça, MD, MSc

CONTACT

5561981882640; correiodofabricio@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Preceptor of Medical Residency in Anesthesiology

Model Details: Prospective, randomized, double-blind and placebo-controlled trial

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 11, 2020
• Study Start: July 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

BR (1)